Insomnia
Conditions
Keywords
Insomnia
Brief summary
Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that has been approved as a treatment of depression in patients that have not responded to a trial of one antidepressant medication. The investigators hypothesize that low frequency TMS exerts inhibitory effect on hyper excitable cortical state in patients with chronic insomnia and therefore is therapeutic. The investigators want to compare the change in insomnia scores between baseline and end of treatment in an open label trial with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).
Detailed description
Insomnia is a common clinical problem that affects about 25 million people in the US. Insomnia exacts health and economic consequences well beyond inadequate and non-restorative sleep. It increases healthcare costs, causes or adds to medical and psychiatric comorbidities, cognitive impairments, accidents, absenteeism and reduced quality of life. Treatment of insomnia is difficult and usually needs a multimodal approach incorporating various cognitive and behavioral approaches in addition to medication treatment. TMS and other neurophysiological studies have shown presence of a diffuse cortical hyper-arousal in patients with chronic insomnia. High frequency TMS (\>1 Hz) has been shown to be activating whereas low frequency TMS (\<1Hz) has been shown to be inhibitory in clinical and neurophysiological studies. TMS has been approved as a treatment of depression in patients who have not responded to a trial of at least one antidepressant medication. The goal of this study is to translate the knowledge learned from neurophysiological studies of insomnia to the clinical treatment of insomnia using TMS as the primary modality. Aim: Compare the change in insomnia scores between baseline and end of treatment with bifrontal low frequency TMS stimulation in 20 patients with primary insomnia using daily stimulation of 3 weeks (15 week days).
Interventions
DEVICETranscranial magnetic stimulation
Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients referred for evaluation and management of insomnia to our sleep disorders clinic will be offered enrollment in this study 2. Patients must meet Diagnostic and Statistical Manual (DSM) IV criteria for Primary insomnia 3. Aged 21-65 years to target relatively healthy adults
Exclusion criteria
1. Patients with co-morbid depression 2. Substance abuse in last two weeks 3. No Psychotropic medication changes 2 weeks before start of TMS treatment and no changes during the 3 week treatment period 4. Patients with a major medical or psychiatric disorder that may be causing or contributing to insomnia: bipolar disorder, psychosis, anxiety disorders, dementia, seizure disorder and chronic pain 5. Patients with ferromagnetic material in their head or within 30 cm of the coil will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index ( PSQI) | three weeks | Change in Pittsburgh sleep quality index scores at the end of three weeks of stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index ( ISI) | three weeks | Change in insomnia severity index scores at the end of three weeks stimulation with transcranial magnetic stimulation. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). |
Countries
United States
Participant flow
Pre-assignment details
Participants were only included in the study if they met all of the inclusion and no exclusion criteria. Participants must have had a primary diagnosis of insomnia in order to qualify.
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Magnetic Stimulation Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Transcranial magnetic stimulation: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Transcranial Magnetic Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 2 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Pittsburgh Sleep Quality Index ( PSQI)
Change in Pittsburgh sleep quality index scores at the end of three weeks of stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)
Time frame: three weeks
Population: All participants who completed the PSQI at baseline through week 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Pittsburgh Sleep Quality Index ( PSQI) | Baseline score | 12.50 score on a scale | Standard Deviation 2.74 |
| Transcranial Magnetic Stimulation | Pittsburgh Sleep Quality Index ( PSQI) | End of week 1 | 11.70 score on a scale | Standard Deviation 3.73 |
| Transcranial Magnetic Stimulation | Pittsburgh Sleep Quality Index ( PSQI) | End of week 2 | 10.37 score on a scale | Standard Deviation 4.04 |
| Transcranial Magnetic Stimulation | Pittsburgh Sleep Quality Index ( PSQI) | End of week 3 | 9.50 score on a scale | Standard Deviation 4.27 |
Secondary
Insomnia Severity Index ( ISI)
Change in insomnia severity index scores at the end of three weeks stimulation with transcranial magnetic stimulation. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time frame: three weeks
Population: All participants who completed the ISI from baseline to week 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Insomnia Severity Index ( ISI) | Baseline | 20.05 score on a scale | Standard Deviation 5.14 |
| Transcranial Magnetic Stimulation | Insomnia Severity Index ( ISI) | End of week 1 | 18.37 score on a scale | Standard Deviation 5.49 |
| Transcranial Magnetic Stimulation | Insomnia Severity Index ( ISI) | End of week 2 | 13.94 score on a scale | Standard Deviation 7.1 |
| Transcranial Magnetic Stimulation | Insomnia Severity Index ( ISI) | End of week 3 | 10.29 score on a scale | Standard Deviation 7.74 |